Missing women

Women are not being included in sufficient numbers in clinical trials of prescription drugs, according to a report released last week by the US General Accounting Office. The report found that the US Food and Drug Administration has not clearly communicated to drug companies the need to include women in numbers proportionate to the numbers of women in the population who might benefit.

The problem was particularly obvious in trials of drugs to treat heart disease, which is the leading cause of death in women. In a survey of drug manufacturers, the GAO found that of 13 heart drugs tested, only one had been tested on a number of women proportionate to the numbers of women who have cardiovascular disease.

In more than half the drugs tested, companies also neglected to analyse data for the two sexes separately to determine if the drug has different effectiveness or toxicity in women, ...

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